AVL 9180 ELECTROLYTE ANALYZER

K961458 · Avl Scientific Corp. · JFP · Jun 12, 1996 · Clinical Chemistry

Device Facts

• Record ID: K961458
• Device Name: AVL 9180 ELECTROLYTE ANALYZER
• Applicant: Avl Scientific Corp.
• Product Code: JFP · Clinical Chemistry
• Decision Date: Jun 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1145
• Device Class: Class 2

Intended Use

The AVL 9180 Electrolyte Analyzer is intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in whole blood, serum or plasma, urine, dialysate solutions, or QC materials as appropriate by minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting. These analytes are commonly used in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders and, as such, have come to be among those which are considered by the American Association of Clinical Chemistry to have the potential of being life threatening if left uncontrolled.

Device Story

Microprocessor-based electrolyte analyzer; uses ion-selective electrodes (ISE) for direct potentiometric measurement of sodium, potassium, chloride, ionized calcium, and lithium. Input: whole blood, serum, plasma, urine, dialysate, or QC materials via syringe, capillary, or microsampler. Operation: automatic sample aspiration, processing, and analysis. Output: results displayed on screen and printed via built-in thermal printer. Used in clinical laboratory settings by trained personnel. Provides quantitative electrolyte values to assist clinicians in diagnosing and managing renal, metabolic, and cardiovascular disorders. Benefits: rapid, automated electrolyte assessment for potentially life-threatening conditions.

Clinical Evidence

Three clinical field tests compared the AVL 9180 against predicate devices (AVL 983, 984, 985, IL 943, Kodak Ektachem XR700) using remnant patient specimens (whole blood, serum, urine). Results showed no significant difference in mean values (P<0.05). Correlation coefficients were generally >0.94 across all analytes. Non-clinical testing included precision studies (20 days, 2 runs/day) and linearity studies using NIST-traceable aqueous standards and patient serum/urine samples, confirming performance within manufacturer claims.

Technological Characteristics

Microprocessor-based instrument; ion-selective electrode (ISE) sensing principle; direct potentiometry. Configurations: Na+/K+/Ca2+, Na+/K+/Cl-, Na+/K+/Li+, Na+/K+, Na+/Li+, or Li+. Connectivity: RS 232 C interface (ASCII/ASTM). Power: 100-240 VAC. Dimensions: 13.2 x 12.4 x 12.0 inches. Weight: 13 lb. Safety: Class I, IP 20, continuous operation. Calibration: 2-point automatic every 4 hours, 1-point automatic per measurement.

Indications for Use

Indicated for patients requiring measurement of sodium, potassium, chloride, ionized calcium, or lithium in whole blood, serum, plasma, urine, or dialysate to assist in the diagnosis and management of renal, metabolic, and cardiovascular disorders.

Regulatory Classification

Identification

A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Predicate Devices

• AVL 983 Na/K/Cl Analyzer (K861087)
• AVL 984 Na/K/iCa Analyzer (K862819)
• AVL 985 Na/K/Li Analyzer (K870657)
• I.L. Model 943 Flame Emission Photometer (not specified)
• Labconco Digital Chloridometer (not specified)

Reference Devices

• AVL 9130 Electrolyte Analyzer
• AVL 9140 Electrolyte Analyzer
• KODAK Ektachem XR700

Submission Summary (Full Text)

{0}

K961458
AVL

# 510(k) Summary

JUN 12 1996

## (a) (1) Submitter's name, address

AVL Scientific Corporation
33 Mansell Court
Roswell, GA 30076

**Contact Person**
Randy Byrd
Quality Assurance Manager
[phone] x 631

**Date of preparation of this summary:**
10 April 1996

## (2) Device trade or proprietary name:

AVL 9180 Electrolyte Analyzer

**Device common or usual name or classification name**
Ion-specific electrolyte analyzer for sodium, potassium and chloride or ionized calcium or lithium.

| Product Nomenclature | Classification Number | Class | Panel |
| --- | --- | --- | --- |
| ELECTRODE, ION-SPECIFIC, CALCIUM | 75 JFP | II | CHEMISTRY |
| ELECTRODE, ION-SPECIFIC, CHLORIDE | 75 CGZ | II | CHEMISTRY |
| FLAME PHOTOMETER, LITHIUM | 75 JIH | II | TOXICOLOGY |
| ELECTRODE, ION-SPECIFIC, POTASSIUM | 75 CEM | II | CHEMISTRY |
| ELECTRODE, ION-SPECIFIC, SODIUM | 75 JGS | II | CHEMISTRY |

## (3) Substantial Equivalence

The AVL 9180 is an improved design of our ISE electrolyte analyzer line to provide the user an ability to only exchange electrodes to change configuration between sodium, potassium and chloride to sodium, potassium and ionized calcium or sodium, potassium and lithium. The 9180, configured for sodium, potassium and chloride is equivalent to the AVL 983 Na/K/Cl Analyzer [K861087]; for sodium, potassium and ionized calcium, to the AVL 984 Na/K/iCa Analyzer [K862819] and; for sodium, potassium and lithium to the AVL 985 Na/K/Li Analyzer [K870657]. Additionally, for sodium, potassium and lithium the AVL 9180 is substantially equivalent to the I.L. Model 943 Flame Emission Photometer and for chloride, to the Labconco Digital Chloridometer.

## (4) Description of the new device

The AVL 9180 Electrolyte Analyzer is a microprocessor-based instrument using ion-selective electrodes for the measurement of sodium, potassium, chloride, ionized calcium and lithium. The user is able to select any one of the measurement modes: whole blood, serum, urine, standard, QC material, acetate or bicarbonate dialysate, depending on the sample type to be analyzed. The analyzer automatically processes the sample through the necessary steps, then prints and displays the results.

In the blood, serum and QC measuring modes, the results for sodium and potassium are reported by default as flame photometry equivalent; chloride, ionized calcium and lithium are reported as ISE direct potentiometric values. The urine mode allows for the measurement of prediluted urine samples for sodium, potassium and chloride. The acetate, bicarbonate and standard modes allow for the measurement of aqueous standards and dialysate solutions and reports as ISE direct potentiometric values.

B

{1}

510(k) Summary
AVL 9180 Electrolyte Analyzer

## (5) Intended use of the device.

The AVL 9180 Electrolyte Analyzer is intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in whole blood, serum or plasma, urine, dialysate solutions, or QC materials as appropriate by minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting. These analytes are commonly used in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders and, as such, have come to be among those which are considered by the American Association of Clinical Chemistry to have the potential of being life threatening if left uncontrolled.

## (6) Technological characteristics of the device.

### Principles of Measurement

The principles of measurement used in the AVL 9180 Electrolyte Analyzer are identical to those principles existing in the electrolyte analyzers to which substantial equivalence is claimed in paragraph (a)(3) above.

### Calibration

The AVL 9180 contains software which permits operation in one of six parameter configurations: Na⁺/K⁺/Ca²⁺, Na⁺/K⁺/Cl⁻, Na⁺/K⁺/Li⁺, Na⁺/K⁺, Na⁺/Li⁺ or Li⁺. A 2-point calibration is performed automatically every 4 hours in READY mode, and a 1-point calibration is performed automatically with each measurement.

### Technical Specifications

#### Measured Values

| Parameter | Range | Display Resolution | units |
| --- | --- | --- | --- |
| whole blood, serum, plasma, dialysate and aqueous solutions | | | |
| Sodium | 40 - 205 | 0.1 | mmol/L |
| Potassium | 1.5 - 15 | 0.1 or 0.01 | mmol/L |
| Chloride | 50 - 200 | 0 or 0.1 | mmol/L |
| ionized Calcium | 0.2 - 5.0 | 0.01 or 0.001 | mmol/L |
| Lithium | 0.1 - 6.0 | 0.01 or 0.001 | mmol/L |
| urine | | | |
| Sodium | 1-300 | 0 | mmol/L |
| Potassium | 4.5 - 120 | 0.1 | mmol/L |
| | (60 - 120 with additional dilution) | | |
| Chloride | 1 - 300 | 0 | mmol/L |

Page 2
(19)

{2}

510(k) Summary
AVL 9180 Electrolyte Analyzer

## Operating Conditions

- Minimum Sample Size: 95 µL
- Sample Type: heparinized whole blood, serum, plasma, urine aqueous standards and acetate or bicarbonate dialysate solutions
- Sample Application: syringe, capillary or AVL Microsampler, collection tube or sample cup
- Sample Input: automatic aspiration
- Ambient Temperature: +15 - +32 °C (59 - 90 °F)
- Relative Humidity: 5% to 95% (non-condensing)
- Type of Measurement: direct potentiometry

## Data Management

- Printout: Built-in thermal printer
- Interface: RS 232 C with selectable baud rate
- Format: 8 bits, no parity, 1 stop bit, ASCII or ASTM (bi-directional)

## Electrical Supply

- Voltage: 100 - 240 VAC (50-60 Hz)
- Power Consumption: 1.4 VA max., 375 max.

## Dimensions and Weight

- Height x width x depth: 13.2 x 12.4 x 12.0 inches (33.5 x 31.5 x 29.5 cm)
- Weight: 13 lb. (6 kg)

## Classifications

- Safety category: I
- Device type: B (according to ÖVE-MG/EN 60601-1, IEC 601-1)
- Mode of operation: continuous operation
- Protection classification: IP 20
- Explosion protection: the device is not designed for operation in explosive environments
- Approvals: CSA, IEC 1010 (TÜV/GS), CE

## (b) (1) Summary of nonclinical tests submitted with the premarket notification for the device. Precision

Typical Within-Run (Swr) Between-Day (Sdd) and Total (St) Precision is determined from 2 runs per day with 2 replicates per run for 20 days on two model AVL 9180 analyzers in each of its three main configurations using samples of each of the specimen types suitable for measurement on the 9180.

20

{3}

510(k) Summary
AVL 9180 Electrolyte Analyzer

# Linearity in Aqueous Standard Solutions

Aqueous linearity standards were gravimetrically prepared from N.I.S.T. traceable salts and measured on each of six AVL 9180 instruments, two of each configuration: Na/K/Cl, Na/K/iCa and Na/K/Li.

| Parameter | Slope | Intercept | Correlation Coefficient | Sy*x | Range | n |
| --- | --- | --- | --- | --- | --- | --- |
| Sodium | 0.99993 | 0.0128 | 0.99995 | 0.666 | 51 - 196 | 300 |
| Potassium | 0.99838 | 0.0119 | 0.99919 | 0.194 | 2.0 - 12.6 | 300 |
| Chloride | 0.97556 | -0.1775 | 0.99994 | 0.674 | 56 - 194 | 100 |
| ionized Calcium | 1.01552 | -0.0078 | 0.99980 | 0.037 | 0.4 - 3.3 | 100 |
| Lithium | 0.99850 | 0.0087 | 0.99985 | 0.038 | 0.3 - 5.3 | 100 |

# Linearity in Serum

Linearity in serum was established with the analysis of two specimen sets in non-clinical tests: commercially prepared serum linearity standards for sodium, chloride and potassium with normal protein content, and a group of random patient serum samples. All samples were analyzed in pairs on each of two of AVL 9180 instruments in each configuration: Na/K/Cl, Na/K/iCa and Na/K/Li. and in pairs on each of several instrument types for comparison to various methods:

vs. Flame Absorbance Emission Spectroscopy (IL 943 Flame Photometer)

| Parameter | Slope | Intercept | Correlation Coefficient | Sy*x | Range | n |
| --- | --- | --- | --- | --- | --- | --- |
| Sodium | 0.9617 | 5.83 | 0.9908 | 2.04 | 104 - 178 | 50 |
| normalized to Na=140 | | 0.47 | | | | |
| Potassium | 1.0249 | 0.015 | 0.9991 | 0.075 | 1.8 - 11.5 | 50 |
| normalized to K=4.0 | | 0.11 | | | | |
| Lithium | 0.9803 | 0.011 | 0.9822 | 0.028 | 0.11 - 0.71 | 15 |

vs. ISE Direct Potentiometry (AVL 983, AVL 984, AVL 985 Electrolyte Analyzers)

| Parameter | Slope | Intercept | Correlation Coefficient | Sy*x | Range | n |
| --- | --- | --- | --- | --- | --- | --- |
| Sodium | 0.9895 | -6.35 | 0.9992 | 0.61 | 110 - 186 | 50 |
| Potassium | 1.0223 | -0.25 | 0.9996 | 0.05 | 2.0 - 11.6 | 50 |
| Chloride | 0.9631 | -1.01 | 0.9995 | 0.51 | 70 - 152 | 50 |
| ionized Calcium | 0.8898 | 0.107 | 0.9960 | 0.021 | 0.67 - 1.66 | 50 |
| Lithium | 0.9923 | 0.008 | 0.9985 | 0.010 | 0.11 - 0.71 | 15 |

vs. ISE Direct Potentiometry with flame correlation (AVL 9130, AVL 9140 Electrolyte Analyzers)

| Parameter | Slope | Intercept | Correlation Coefficient | Sy*x | Range | n |
| --- | --- | --- | --- | --- | --- | --- |
| Sodium | 0.9856 | -2.02 | 0.9856 | 1.21 | 104 - 179 | 50 |
| Potassium | 0.9992 | 0.02 | 0.9994 | 0.05 | 1.9 - 11.8 | 50 |
| Chloride | 1.0026 | -5.31 | 0.9989 | 0.73 | 70 - 152 | 50 |
| ionized Calcium | 1.0023 | 0.040 | 0.9954 | 0.022 | 0.62 - 1.54 | 50 |

Page 4

{4}

510(k) Summary
AVL 9180 Electrolyte Analyzer

# Linearity in Urine

Linearity in urine was evaluated with the analysis of random patient urine specimens on two, AVL 9810 Electrolyte Analyzers in the Na/K/Cl configuration and, in duplicate on two AVL 983 Na/K/Cl Electrolyte Analyzers for sodium, potassium and chloride; on a IL 943 Flame Photometer for sodium and potassium; and on a Labconco Digital Chloridometer for chloride.

vs. direct ISE (AVL 983) in urine

| Parameter | Slope | Intercept | Correlation Coefficient | Sy*x | Range | n |
| --- | --- | --- | --- | --- | --- | --- |
| Sodium | 1.0173 | -7.4382 | 0.9973 | 5.55 | 4 - 262 | 56 |
| Potassium | 1.0312 | -0.1539 | 0.9976 | 2.24 | 6 - 147 | 56 |
| Chloride | 0.9817 | 2.4630 | 0.9972 | 5.64 | 16 - 299 | 56 |

vs. flame absorbance emission spectroscopy (IL 943 Flame Photometer) in urine

| Parameter | Slope | Intercept | Correlation Coefficient | Sy*x | Range | n |
| --- | --- | --- | --- | --- | --- | --- |
| Sodium | 0.9173 | 0.5627 | 0.9901 | 10.64 | 7 - 285 | 56 |
| Potassium | 1.0312 | -0.1539 | 0.9976 | 2.24 | 6 - 147 | 56 |

vs. chloridometry (Labconco Digital) Chloridometer in urine

| Parameter | Slope | Intercept | Correlation Coefficient | Sy*x | Range | n |
| --- | --- | --- | --- | --- | --- | --- |
| Chloride | 0.9817 | 2.4630 | 0.9972 | 5.64 | 16 - 299 | 56 |

## (b) (2)

Summary of clinical tests submitted with the premarket notification for the device. Three field tests were conducted to demonstrate the correlation of the AVL 9180 to legally marketed predicate devices in a clinical setting, operated by personnel trained to perform and report these analyses. Specimens analyzed in these tests were remnant from patient specimens collected for routing analysis on existing instrumentation.

In all evaluations, there was no difference in mean values ($P&lt;0.05$) obtained on measurement by the AVL 9180 and the predicate device. The table below provides data representative of that collected in these field tests.

vs. thin-film slide; KODAK Ektachem XR700 in serum

| Parameter | Slope | Intercept | Correlation Coefficient | Sy*x | Range | n |
| --- | --- | --- | --- | --- | --- | --- |
| Sodium | 1.0459 | -6.6196 | 0.9495 | 1.67 | 125 - 158 | 103 |
| Potassium | 1.0895 | -0.2740 | 0.9873 | 0.10 | 2.8 - 6.2 | 103 |
| Chloride | 0.9505 | 6.2577 | 0.9762 | 1.32 | 85 - 125 | 103 |

Page 5

{5}

510(k) Summary
AVL 9180 Electrolyte Analyzer

| Parameter | Slope | Intercept | Correlation Coefficient | Sy*x | Range | n |
| --- | --- | --- | --- | --- | --- | --- |
| Sodium | 0.9208 | 10.1267 | 0.9485 | 1.19 | 112 - 142 | 102 |
| Potassium | 0.9820 | 0.0879 | 0.9933 | 0.16 | 3.2 - 12.3 | 102 |
| Chloride | 0.8346 | 13.3572 | 0.9674 | 1.45 | 83 - 118 | 102 |
| ionized Calcium | 1.0020 | 0.0800 | 0.9783 | 0.02 | 0.78 - 1.37 | 102 |

vs. direct ISE (AVL 984 Electrolyte Analyzer) in whole blood

| Parameter | Slope | Intercept | Correlation Coefficient | Sy*x | Range | n |
| --- | --- | --- | --- | --- | --- | --- |
| Sodium | 0.9918 | -6.4874 | 0.9682 | 0.94 | 123 - 149 | 102 |
| Potassium | 0.9671 | -0.0380 | 0.9974 | 0.10 | 3.3 - 12.8 | 102 |
| ionized Calcium | 0.9491 | 0.0374 | 0.9825 | 0.02 | 0.87 - 1.47 | 102 |

vs. direct ISE (AVL 985 Electrolyte Analyzer) in whole blood

| Parameter | Slope | Intercept | Correlation Coefficient | Sy*x | Range | n |
| --- | --- | --- | --- | --- | --- | --- |
| Lithium | 1.0799 | -0.0203 | 0.9986 | 0.03 | 0.19 - 3.34 | 104 |

vs. flame absorbance emission spectroscopy (IL 943 Flame Photometer) in serum

| Parameter | Slope | Intercept | Correlation Coefficient | Sy*x | Range | n |
| --- | --- | --- | --- | --- | --- | --- |
| Lithium | 0.9720 | 0.0163 | 0.9957 | 0.02 | 0.23 - 1.13 | 15 |

(b) (3) Conclusions drawn from the clinical and nonclinical trials.

Analysis of the comparative measurement presented in the 510(k) for this device, together with the linearity and precision data collected during these clinical and nonclinical trials demonstrates that the AVL 9180 in any of the available configurations for measurement, is safe and effective. There is no significant difference in the measurement values obtained on whole blood, serum or urine with the AVL 9180 and those obtained with predicate devices in this study and the precision and linearity demonstrated both in clinical and non clinical trials is within the manufacturers claims and expectations.

Page 6
23